Techni Med, Inc. dba The Compounder
Form 483 issued August 5, 2015 · Aurora, Illinois
- Inspection
- May 7, 2015 – Jul 9, 2020
- Investigator
- Christina A. Miller
- Observations
- 10
- Pages
- 6
- FEI number
- 3004504906
In short: On August 5, 2015, FDA issued a Form 483 with 10 observations to Techni Med, Inc. dba The Compounder in Aurora, Illinois (FEI 3004504906) after an inspection that ran May 7, 2015 – Jul 9, 2020. The investigator was Christina A. Miller. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 10 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Procedures designed to prevent microbiological contamin::nion of dmg products purporting to be sterile do not int'lude…
- 04
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmTechni Med, Inc. dba The Compounder history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Techni Med, Inc. dba The Compounder?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Techni Med, Inc. dba The Compounder?
Christina A. Miller is named on this Form 483, for the inspection of May 7, 2015 – Jul 9, 2020. Each investigator has a profile showing what they cite most.
When was Techni Med, Inc. dba The Compounder inspected by FDA?
The inspection ran May 7, 2015 – Jul 9, 2020, and the Form 483 is dated August 5, 2015.
How do I get the full Form 483 for Techni Med, Inc. dba The Compounder?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.